Cholera
Conditions
Brief summary
Develop a scalable approach for delivering water, sanitation, and hygiene (WASH) messages to households in areas with confirmed cholera patients in Dhaka, Bangladesh. This will be done by conducting formative research through in-depth interviews, focus group discussions, and intervention planning workshops with households in areas with confirmed cholera patients and government officials to identify perceptions of WASH behaviors and to inform the development of a mobile health intervention (mHealth) for this population. This intervention approach will then be piloted in a subset of households, and revised according to feedback. Then the investigators will conduct a randomized controlled of the refined mHealth intervention.
Detailed description
Aim 1. Develop an evidence and theory based WASH mHealth intervention for households in areas with confirmed cholera patients in Dhaka, Bangladesh through formative research 1. Conduct formative research through in-depth interviews, focus group discussions, and intervention planning workshops with caregivers and household members of young children, and government officials to identify perceptions of WASH behaviors and to inform the development of intervention materials. 2. Pilot the WASH mHealth intervention in a subset of households, and revise according to feedback. Aim 2: Evaluate the effectiveness of the developed WASH mHealth intervention in increasing WASH behaviors and reducing fecal contamination on hands and in stored drinking water by conducting a RCT 1. Recruit and prospectively follow for 12 months 120 households (600 participants, 4 per household) with a child under five years of age assigned to one of two study arms (60 households per arm). The first arm will receive the CHoBI7 mHealth program (CHoBI7 mHealth program Arm) and the second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). 2. Compare the 2 study arms using structured observation of handwashing with soap at stool and food related events, unannounced spot checks of the presence of soap in the cooking and latrine areas of the household, and fecal coliform counts on caregiver hands and in stored drinking water.
Interventions
BEHAVIORALCHoBI7 mHealth program Arm
We will start delivery of this intervention with a pictorial module delivered in the home during two 30 minute visits on cholera transmission and prevention after enrollment. Households will be provided a handwashing station, a covered water vessel, and chlorine tablets. Households will then receive the CHoBI7 WASH mHealth program voice and text messages on handwashing with soap and water treatment bi-weekly.
BEHAVIORALgeneral message on oral rehydration solution (ORS)
general message on oral rehydration solution (ORS)
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* At least one household member must report ownership of an active mobile phone in their possession on the day of enrollment
Exclusion criteria
* Household has a tap or basin with running water inside their home.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events | 1 month, 3 months | Handwashing with soap measured by 5-hour structured at the following food and stool related events in the household: (1) after using the toilet; (2) after cleaning a child's anus; (3) before eating; (4) before feeding a child; and (5) before preparing food. |
| Post Intervention Chlorine Concentration in Drinking Water | 7 Days after enrollment | Free available chlorine in stored household drinking water \>0.2 mg/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Diarrheal Events | Up to 3 months | Participants will be asked if they have had diarrhea in the past week at the follow-up visits during the 3 month surveillance visit. Percentage of diarrheal events is reported. |
Countries
Bangladesh
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CHoBI7 mHealth Program Arm The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) .
CHoBI7 mHealth program Arm: We will start delivery of this intervention with a pictorial module delivered in the home during two 30 minute visits on cholera transmission and prevention after enrollment. Households will be provided a handwashing station, a covered water vessel, and chlorine tablets. Households will then receive the CHoBI7 WASH mHealth program voice and text messages on handwashing with soap and water treatment bi-weekly.
general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS) | 138 |
| Standard Recommendation Arm The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS).
general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS) | 146 |
| Total | 284 |
Baseline characteristics
| Characteristic | CHoBI7 mHealth Program Arm | Standard Recommendation Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 63 Participants | 58 Participants | 121 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants | 88 Participants | 163 Participants |
| Age, Continuous | 21 years STANDARD_DEVIATION 15 | 24 years STANDARD_DEVIATION 17.5 | 21 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 146 Participants | 284 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Bangladesh | 138 Participants | 146 Participants | 284 Participants |
| Sex: Female, Male Female | 72 Participants | 77 Participants | 149 Participants |
| Sex: Female, Male Male | 66 Participants | 69 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 138 | 0 / 146 |
| other Total, other adverse events | 0 / 138 | 0 / 146 |
| serious Total, serious adverse events | 0 / 138 | 0 / 146 |
Outcome results
Primary
Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events
Handwashing with soap measured by 5-hour structured at the following food and stool related events in the household: (1) after using the toilet; (2) after cleaning a child's anus; (3) before eating; (4) before feeding a child; and (5) before preparing food.
Time frame: 1 month, 3 months
Population: Participants that were available are reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CHoBI7 mHealth Program Arm | Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events | 1 month | 37 Participants |
| CHoBI7 mHealth Program Arm | Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events | 3 months | 27 Participants |
| Standard Recommendation Arm | Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events | 1 month | 4 Participants |
| Standard Recommendation Arm | Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events | 3 months | 10 Participants |
Primary
Post Intervention Chlorine Concentration in Drinking Water
Free available chlorine in stored household drinking water \>0.2 mg/L
Time frame: 7 Days after enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CHoBI7 mHealth Program Arm | Post Intervention Chlorine Concentration in Drinking Water | 23 Water samples with chlorine >0.2 mg/L |
| Standard Recommendation Arm | Post Intervention Chlorine Concentration in Drinking Water | 0 Water samples with chlorine >0.2 mg/L |
Secondary
Percentage of Diarrheal Events
Participants will be asked if they have had diarrhea in the past week at the follow-up visits during the 3 month surveillance visit. Percentage of diarrheal events is reported.
Time frame: Up to 3 months
Population: Individuals with clinical surveillance data available from follow-up visits during the 3 month-surveillance period
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CHoBI7 mHealth Program Arm | Percentage of Diarrheal Events | 11 percentage of diarrheal events |
| Standard Recommendation Arm | Percentage of Diarrheal Events | 4 percentage of diarrheal events |